A critical time when existing antiseptic preparation or materials lose effectiveness in providing necessary prophylaxis is during surgical procedures. In this instance, subdermal flesh and/or internal body organs may be exposed to microorganisms. A typical procedure is to apply a conventional antiseptic solution, lotion, etc., to the dermis prior to performing a surgical incision. Such prophylactic materials are subjected to body fluids such as blood, perspiration, urine, gastric fluids of high acidity, and the like, as well as alcohol or other sterilants common to surgical procedure. Conventional antiseptic preparations lack resistance to such fluids and thus are prone to removal during surgery. Similarly, after surgical closure, the possibility of infection exists, and protection of the wound is necessary. In this instance, resistance to perspiration, urine, water, and other fluids, and resistance to removal via contact with bandages and the like is highly desirable but often unobtainable with existing preparations.
Long term protection is desirable to prevent infection and also to reduce the frequency of antiseptic application. Similarly, antiseptic application is desirable for non-surgical procedures such as treatment of cuts, punctures, scratches, and the like where medical attention may or may not be sought, hypodermic inoculations treatment of non-human animal wounds or infection, and even as a protective coating for the hands of the medical practitioner to forestall the transmission of pathogens to his patients.
U.S. Pat. No. 4,374,126 discloses an iodine film-forming composition comprising ethyl alcohol and carboxylated polyacrylates, a disfunctional amide that cross-links the acrylate polymer, an adhesion promoter and an antimicrobial agent. This film-forming solution contains, preferably, 1.0 percent iodine, being an effective biocide.
The film-forming solution disclosed in U.S. Pat. No. 4,374,126, when applied to the skin, forms a thin, continuous film containing iodine. The film adheres to the skin and is not soluble in water or alcohol but remains permeable to water moisture and carbon dioxide. The film can, however, be removed by natural soap and water. The elemental iodine slowly leaches out of the film and keeps the skin in contact virtually sterile. The initial disinfection is provided by the alcohol which is a carrier of the composition.
However, there are several disadvantages to utilizing this solution. Although the film forming solution of U.S. Pat. No. 4,374,126 serves the above purpose very well, it has been found that the concentration of active iodine falls rather quickly with time, and when it reaches a level of approximately 50% to 60% of its original concentration. the degradation stops and the concentration of iodine levels off. Furthermore, the film is too sticky to the skin and is not easily removed by water or alcohol. This causes inconvenience to the healthcare personnel in removing the film from the patient Additionally, iodine leaches out of the film slowly from the film.
Therefore, it is desirable to produce a skin preparation composition which prevents iodine degradation and increases the effectiveness and shelf-life of the composition, as well as the ability to easily remove the film from the patient.